Study of Blood and Urine Samples in Patients With Newly Diagnosed Localized Prostate Cancer Treated With Hormone Therapy and Radiation Therapy. ICORG 06-15

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00955435
First received: August 7, 2009
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is studying blood and urine samples in patients with newly diagnosed localized prostate cancer treated with hormone therapy and radiation therapy.


Condition Intervention
Prostate Cancer
Drug: bicalutamide
Drug: releasing hormone agonist therapy
Genetic: protein expression analysis
Genetic: proteomic profiling
Other: laboratory biomarker analysis
Radiation: radiation therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Proteomic Analysis of the Combined Hormonal Therapy and Radiation Therapy for Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by ICORG- All Ireland Cooperative Oncology Research Group:

Primary Outcome Measures:
  • Changes in serum and urine proteomic profiles [ Time Frame: Ongoing until patient progression ] [ Designated as safety issue: No ]
  • Prognostic and biochemical markers of early disease progression [ Time Frame: Ongoing until patient progression ] [ Designated as safety issue: No ]
  • Protein expression and temporal alterations [ Time Frame: Ongoing until patient progression ] [ Designated as safety issue: No ]
  • Molecular targets [ Time Frame: Ongoing until patient progression ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2005
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Detect changes in serum and urine proteomic profiles that predict outcome in patients with newly diagnosed localized prostate cancer treated with hormonal therapy and radiotherapy.
  • Identify prognostic and biochemical markers of early disease progression in patients treated with this regimen.
  • Identify unique protein expression and temporal alterations, in these profiles, that facilitate understanding of the factors predicting relapse or toxicity.
  • Identify molecular signatures that allow identification of targets for therapeutic intervention.

OUTLINE: This is a multicenter study.

Patients receive induction hormones* (bicalutimide and releasing-hormone agonist) for approximately 4 months prior to starting radiotherapy. Patients then receive radiotherapy consisting of 74 Gy up to a maximum of 81 Gy to the prostate gland per standard treatment.NOTE: * Patients receiving short-term hormonal treatment for 4-8 months are eligible to participate in the trial.

Blood and urine samples are collected at baseline, and periodically during and after induction therapy for proteomic analysis.

After completion of study therapy, patients are followed up periodically for up to 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with localised prostate cancer who will receive radiation therapy plus hormonal therapy, for 4 - 8 months, are eligible for the trial. Patients will be eligible to participate in the trial provided they have not received prior therapy for their prostate cancer. It is planned that 60 patients will participate in the research study. All patients will receive approx 4 months of induction hormone therapy (LHRH agonist and Bicalutamide) prior to starting radiotherapy treatment.

Criteria

Inclusion criteria:

  1. Age 18 years or over.
  2. Histologically confirmed invasive adenocarcinoma of the prostate (by TURP or TRUS).
  3. Localised prostate cancer with a Gleason score 7
  4. Short term hormonal treatment 4-8 months
  5. Performance status of KPS ≥ 60 / WHO 0-2
  6. Absence of distant metastases

Exclusion criteria:

  1. The patient has previously received treatment for prostate cancer other than TURP/ TRUS
  2. The patient has had a bilateral orchidectomy
  3. The patient has previously received hormonal treatment for prostate cancer
  4. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial. In the opinion of the investigator, any evidence of severe or uncontrolled systematic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease
  5. The patient has or had other co-existing malignancies within the past 5 years other than non- melanoma skin cancer
  6. Treatment with non-approved or investigational drug within 30 days before day one of the trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955435

Locations
Ireland
Saint Luke's Radiation Oncology Network
Dublin, Ireland, 6
UPMC Beacon Hospital
Dublin, Ireland, 18
Sponsors and Collaborators
ICORG- All Ireland Cooperative Oncology Research Group
Investigators
Principal Investigator: John Gerard Armstrong, MD, MB, MRCPI Saint Luke's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier: NCT00955435     History of Changes
Other Study ID Numbers: CDR0000639281, ICORG-06-15, EU-20921
Study First Received: August 7, 2009
Last Updated: January 20, 2014
Health Authority: Ireland: Health Information and Quality Authority

Keywords provided by ICORG- All Ireland Cooperative Oncology Research Group:
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Bicalutamide
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014